Looks like the patients and the docs there are in
Post# of 153773
(Total Views: 614)
Posted On: 04/17/2021 6:27:27 PM
Looks like the patients and the docs there are in a very difficult situation. Hence the doctors have been pressuring the Philippines FDA to provide them the authority to prescribe LL. With LL’s safety record, the docs are aware that this is not a big risk. Generally they will have tried the SOC and failed before they will prescribe our LL. Note the press release below says the doctors WANT THIS OPTION. So I am less concerned of the CSP language being a big obstacle, especially as the medical community gets educated and sees the successes. Doctors hate to see their patient die!
CSP Press Release:
“Recently, the FDA granted Compassionate Special Permits (CSP) for Leronlimab as requested by medical specialists for the treatment of COVID-19 patients.
It is clarified that a CSP is a special permit granted to physicians or hospitals to use investigational drugs or drugs which are not yet registered or in the process of registration here in the Philippines for the treatment of seriously ill patients. A CSP can only be requested by physicians in charge or by the institution where patients are being treated, who takes full responsibility for the use and dispensing of the requested drug product. The CSP holder must fully inform the patient of the investigational status of the product, and provide a report to the FDA of the outcomes for every patient given the product.”
CSP Press Release:
“Recently, the FDA granted Compassionate Special Permits (CSP) for Leronlimab as requested by medical specialists for the treatment of COVID-19 patients.
It is clarified that a CSP is a special permit granted to physicians or hospitals to use investigational drugs or drugs which are not yet registered or in the process of registration here in the Philippines for the treatment of seriously ill patients. A CSP can only be requested by physicians in charge or by the institution where patients are being treated, who takes full responsibility for the use and dispensing of the requested drug product. The CSP holder must fully inform the patient of the investigational status of the product, and provide a report to the FDA of the outcomes for every patient given the product.”
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